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GSK’s Jemperli received approval in Europe and the US for endometrial cancer

  • Writer: ipharmaservices
    ipharmaservices
  • Apr 23, 2021
  • 1 min read

GSK has announced that the US FDA has approved Jemperli (dostarlimab), a programmed death receptor-1 (PD-1) for endometrial cancer.

The product was approved for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.




European Commission has also given conditional marketing authorization for women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer. Jemperli is the first PD-L1 inhibitor approved for endometrial cancer.



The approval by the European Commission and FDA was based on the GARNET study. GARNET is a multicentre, non-randomized, open-label study. Overall response rate and duration of response were considered as primary endpoints. The overall response rate was 42%, ≥six months duration of response was observed in 93% of patients.





The drug is administered as a 500 mg intravenous infusion every three weeks for four doses, followed by 1,000 mg administered every six weeks.


In the US, the product received the breakthrough designation in May 2019.




 

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